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Senior Manager Statistical Programming
A company is looking for a Senior Manager in Analysis Oversight Statistical Programming. Key Responsibilities Lead the development of Analysis Data Model (ADaM) and Table, Figure, and Listing (TFL) deliverables Monitor vendor performance and address programming challenges during governance meetings Provide statistical guidance and mentorship to programming colleagues while ensuring compliance with regulatory standards Required Qualifications PhD in Biostatistics/Computer Science with 2 years of experience, or MS with 6 years, or BS with 8 years of experience Minimum 3 years of experience leading studies in virology, oncology, or inflammation therapeutic areas Strong expertise in developing ADaM and TFLs Proven track record in delivering high-quality statistical programming datasets Deep knowledge of GCP, ICH guidelines, and regulatory requirements related to quality oversight
A company is looking for a Senior Manager in Analysis Oversight Statistical Programming.
Key Responsibilities
Lead the development of Analysis Data Model (ADaM) and Table, Figure, and Listing (TFL) deliverables
Monitor vendor performance and address programming challenges during governance meetings
Provide statistical guidance and mentorship to programming colleagues while ensuring compliance with regulatory standards
Required Qualifications
PhD in Biostatistics/Computer Science with 2 years of experience, or MS with 6 years, or BS with 8 years of experience
Minimum 3 years of experience leading studies in virology, oncology, or inflammation therapeutic areas
Strong expertise in developing ADaM and TFLs
Proven track record in delivering high-quality statistical programming datasets
Deep knowledge of GCP, ICH guidelines, and regulatory requirements related to quality oversight